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    Clinical Trial Results:
    OPEN LABEL PHASE II STUDY TO EVALUATE THE SAFETY OF STANDARD INDUCTION AND CONSOLIDATION THERAPY IN COMBINATION WITH DASATINIB IN NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL)

    Summary
    EudraCT number
    		 2010-022854-18
    Trial protocol
    		 DE  
    Global end of trial date
    30 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2020
    First version publication date
    09 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GMALL-PH-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01724879
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goethe Universität Frankfurt
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt, Germany, 60590
    Public contact
    Studienzentrale, Med. Klinik II, Goethe Universität Frankfurt, +49 (0)6963016366, gmall@em.uni-frankfurt.de
    Scientific contact
    Studienzentrale, Med. Klinik II, Goethe Universität Frankfurt, +49 (0)6963016366, gmall@em.uni-frankfurt.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the feasibility of a combination of Dasatinib and standard chemotherapy in adult ALL
    Protection of trial subjects
    A Data Safety Monitoring Board (DSMB) has been instituted for this study in order to ensure its ongoing safety. The committee includes 3 members. Safety review meeting will be held as required by the sponsor. Enrollment to the study will continue throughout the scheduled meetings of the DSMB. Decisions on trial termination, amendment or cessation of patient recruitment based on safety findings will be based on recommendations of the DSMB.
    Background therapy
    		 PREPHASE (recommended standard of care): Dexamethasone; Cyclophosphamide; Intrathecal (IT) MTX INDUCTION PHASE I (starting at day 6): Dexamethasone; Vincristine; PEG-asparaginase; G-CSF INDUCTIONPHASE II (starting at day 26): Methotrexat i.th.; Cyclophosphamide; Cytarabine; 6-Mercaptopurine; G-CSF; Cranial irradiation parallel to Induction II in CR patients CONSOLIDATION I (starting at “day 71” for patients in CR after induction therapy): Dexamethasone (orally); Vindesine; HD-Methotrexate; VP16; HD-Cytarabine; G-CSF; intrathecal MTX/AraC/DEX
    Evidence for comparator
    		 N.A.
    Actual start date of recruitment
    08 Aug 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 17-Nov-2011 FPI (First Patient In) 11-Apr-2013 19th Patient out 03-May-2013 Recruitment interrupted after interim safety analysis for DSUR and consultation of DSMB (decision not to amend the study, but to stop the trial finaly was done later in 2015)

    Pre-assignment
    Screening details
    		 Screening applies to confirmed new diagnosis of Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia (ALL). BCR-ABL Assessment is standard of care for ALL. Patients aged 18-55 years. First-line-Therapy (Not previously treated except for prephase therapy)

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N.A. (open-label single-arm phase II study) Dasatinib+ Chemotherapy

    Arms
    Arm title
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Arm description
    		 Dasatinib + Backbone Chemotherapy as described above
    Arm type
    		 open-label single-arm study

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    ATC: LO1XE06
    Other name
    Sprycel
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    140mg /day, in case of toxicitiy dose reduction to 70mg/day possible

    Number of subjects in period 1
    		Dasatinib+ Chemotherapy (open-label single-arm study)
    Started
    19
    Induction I
    19
    Induction II
    19
    Interval 1
    14
    Consolidation I
    13
    Interval 2
    12
    Completed
    12
    Not completed
    7
         Adverse event, serious fatal
    4
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Planned subject number was a maximum of 20 patients evaluable for feasibility. Before halt of recruitment in April 2013, 19 patients had been enrolled and could be analyzed. The analysis was performed based on the data available from the closed database (29-Oct-2013). All enrolled Patients (N=19) belong to the intention-to-treat analysis set, which is therofre identical to the full analysis set. All Patients enter feasibility analysis. For the purpose of this report no further analysis set has been defined.

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 19 19
    Age categorical
    ALL Patients 18-55 Years old
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        18-55 Years
    		 19 19
    Age continuous
    Age Median: 45 yrs Range: 31-53 yrs 18-25 yrs: N=0; 0% 25-45 yrs: N=11; 58% 46-55 yrs: N=8; 42%
    Units: years
        median (full range (min-max))
    		 45 (31 to 53) -
    Gender categorical
    Gender Male: N=12; 63%
    Units: Subjects
        Female
    		 7 7
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Dasatinib+ Chemotherapy (open-label single-arm study)
    Reporting group description
    		 Dasatinib + Backbone Chemotherapy as described above

    Primary: survival and treatment related discontinuation

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    End point title
    		 survival and treatment related discontinuation [1]
    End point description
    20 eligible subjects with newly diagnosed Philadelphia positive ALL will be included in the study for assessment of feasibility. Patients who are enrolled but do not receive the first dose of Dasatinib will be replaced. A death rate of greater than 20% during induction therapy and a discontinuation rate of greater than 35% by or before end of study treatment due to death or treatment-related toxicity will be considered to constitute non-feasibility. If these thresholds, based on projected recruitment of 20 patients, are already exceeded before 20 patients are enrolled, the study will be stopped. Results: 19 patients were evaluable. Four patients died during induction therapy (21%) and one patient discontinued induction II therapy due to adverse events (PR on day 26, CR achieved after end of study on day 46). 2 additional patients discontinued therapy after induction in CR due to adverse events (due to probably chemotherapy related events). Overall Discontinuation Rate = 37%
    End point type
    Primary
    End point timeframe
    after consolidation (after approx. 3 Month of treatment)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Analysis is done by descriptive statistics: It is expected that the mortality rate (excluding mortality due to persisting or progressive leukema) will not exceed 20% during study treatment, and that the rate of treatment-related discontinuation due to death or treatment-related toxicity will not exceed 35%. Rates exceeding these thresholds will be considered to constitute non-feasibility. Analysis will be made by descriptive statistics.
    End point values
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Number of subjects analysed
    19
    Units: Patients (percentages)
        treatment related discontinuation
    3
        Death
    4
    No statistical analyses for this end point

    Secondary: Molecular CR rate

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    End point title
    		 Molecular CR rate
    End point description
    MRD analysis, i.e. the determination of the molecular remission status based on the quantitative measurement of the BCR-ABL transcript was scheduled at screening/time point of diagnosis and at different time-points during treatment. Patients with non quantifiable MRD status or insufficient sensitivity (less than 10-4) remained unevaluable. On Day 46 (after induction therapy) 11 patients with cytologic CR were evaluable for MRD analysis. 6 of these patients had achieved a molecular CR (55%). At end of study 8 patients were evaluable for MRD testing and 6 had a molecular CR (75%).
    End point type
    Secondary
    End point timeframe
    After consolidation (after approx 3 Month of treatment)
    End point values
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Number of subjects analysed
    8
    Units: Patients with molecular CR after Cons.
    6
    No statistical analyses for this end point

    Secondary: Hematologic CR rate at end of induction II

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    End point title
    		 Hematologic CR rate at end of induction II
    End point description
    In 14 of 19 enrolled patients (74%) a CR was achieved on day 46 during study.
    End point type
    Secondary
    End point timeframe
    After induction II
    End point values
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Number of subjects analysed
    19
    Units: Number of Patients with CR after Ind II
    14
    No statistical analyses for this end point

    Secondary: BCR-ABL mutations occuring during treatment

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    End point title
    		 BCR-ABL mutations occuring during treatment
    End point description
    no mutations have been observed
    End point type
    Secondary
    End point timeframe
    Sequencing of MRD-Testings until EOS
    End point values
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Number of subjects analysed
    19
    Units: Patients with Mutations in BCR-ABL
    0
    No statistical analyses for this end point

    Secondary: Grade III and IV toxicity by CTC

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    End point title
    		 Grade III and IV toxicity by CTC
    End point description
    Induction I (14/19 Patients) Hemoglobin (6), Leukocytes (7), Neutrophils (4), Platelets (10), Fibrinogen (2), Diarrhea (2), Pleural effusion - grade 2 (2) Induction II (17/19 Patients) Hemoglobin (8), Leukocytes (6), Neutrophils (5), Platelets (10), Fibrinogen (2), Coagluation Other - ATIII deficiency (3), Anorexia / Nausea (3) Febrile Neutropenia (2), Infection -documented clinically - with grade 3 or 4 ANC/unknown ANC (2/1), ALT (3), Bilirubin (4), GGT (3), Pain - Headache (2), Pleural effusion - grade 2 (2) Intervall 1 (10/14 Patients) Hemoglobin (7), Leukocytes (3), Neutrophils (4), Platelets (7), Nausea (2), ALT (2), Bilirubin (2), GGT (3), Pain – Head/headache (2). Consolidation I (11/13 Patients) Hemoglobin (6), Leukocytes (2), Neutrophils (4), Platelets (5) Mucositis/stomatitis (4), Renal failure (2). Intervall 2 (8/12 Patients) Hemoglobin (5), Leukocytes (3), Neutrophils (4), Platelets (6), Mucositis/stomatitis (5), Vomiting (2), ALT (2), AST (2).
    End point type
    Secondary
    End point timeframe
    separate anlysis for therapyphases: Induction I (19 Patients); Induction II (19 Patients); Intervall 1 (14 Patients); Consolidation I (13 Patients); Intervall 2 (12 Patients)
    End point values
    		 Dasatinib+ Chemotherapy (open-label single-arm study)
    Number of subjects analysed
    19 [2]
    Units: Patients
        Induction I (N=19)
    14
        Induction II (N=19)
    17
        Interval 1 (N=14)
    10
        Consolidation I (N=13)
    11
        Interval 2 (N=12)
    8
    Notes
    [2] - Patients with AEs
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall timeframe divided into therapy phases as reporting groups: Induction I, Induction II, Interval 1, Consolidation I, Interval 2
    Adverse event reporting additional description
    only events with CTCAE grade 3 or 4 and pleural effusions of any grade 12 SAE reported under Therapy (1 SAE reported post study after EOS: "Metabolic Laboratory, Liver Associated", has been included as non-serious-AE in this report)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    1 - Induction I
    Reporting group description
    		 Patients in Induciton I (N=19)

    Reporting group title
    2 - Induction II
    Reporting group description
    		 -

    Reporting group title
    3 - Interval 1
    Reporting group description
    		 -

    Reporting group title
    4 - Consolidation I
    Reporting group description
    		 -

    Reporting group title
    5 - Inverval 2
    Reporting group description
    		 -

    Serious adverse events
    		 1 - Induction I 2 - Induction II 3 - Interval 1 4 - Consolidation I 5 - Inverval 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    7 / 19 (36.84%)
    0 / 14 (0.00%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
    4
    0
    0
    0
         number of deaths resulting from adverse events
    0
    4
    0
    0
    0
    Nervous system disorders
    Seizure (1 SAE, non fatal, not attributed to study drug)
    Additional description: In one patient a seizure occurred and subsequently a temporary behavioral change was reported as SAE. The case was classified as neurological event. Magnetic resonance imaging was performed and revealed lesions
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CNS hemorrhage (2 SAE, 1 fatal outcome, 2 with possible attribution to study drug)
    Additional description: One fatal subdural bleeding occurred in association with thrombocytopenia grade 3 in induction phase II. A second subdural and cerebral bleeding was observed after consolidation I and is resolved in the meantime.
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Lung hemorrhage (1 SAE, 1 fatal outcome, 1 with potential attribution to study drug)
    Additional description: One fatal lung bleeding occurred in association with thrombocytopenia grade 4 during induction phase II.
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Sepsis (2 SAE, 2 fatal outcome, 2 not attributed to study drug)
    Additional description: Two cases of fatal sepsis have been reported as SAE. Sepsis in neutropenia is a well known risk in the therapy of ALL with chemotherapy alone independent of the additional use of tyrosine kinase inhibitors such as Dasatinib.
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Vomiting/Nausea (1 SAE, non fatal, 1 with potential attribution to study drug)
    Additional description: Nausea and vomiting are documented side effects of chemotherapy for ALL. In one patient recurrent vomiting was observed and reported as SAE. The patient has been admitted to hospital. The vomitus contained haematin. A gastroscopy revealed no abnormal
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity (5 SAEs, non fatal, 4 with potential attribution to study drug)
    Additional description: Elevated liver enzymes and hyperbilirubinemia are documented side effect of chemotherapy for ALL. 5 SAEs have been reported, 1 SAE was reported post study and is not listed below
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 19 (15.79%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal toxicity (1 SAE, non fatal, 1 potential attribution to study drug)
    Additional description: Elevated creatinine levels after consolidation I have been reported in one patient. Consolidation I includes a 24h-infusion with high-dose methotrexate. The patient displayed prolonged methotrexate clearance.
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 1 - Induction I 2 - Induction II 3 - Interval 1 4 - Consolidation I 5 - Inverval 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 19 (73.68%)
    17 / 19 (89.47%)
    10 / 14 (71.43%)
    11 / 13 (84.62%)
    8 / 12 (66.67%)
    Vascular disorders
    Thrombosis/thrombus/embolism
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    General disorders and administration site conditions
    Fibrinogen
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 19 (10.53%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Coagulation Other - AT-III deficiency
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Constitutional Symptomes - Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hemorrhage GU- Vagina
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hemorrhage - Rectum
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    2 / 14 (14.29%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    Immune system disorders
    Allergy
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    pleural effusion (grade 2)
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 19 (10.53%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    Pain upper respiratory
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pulmonary edema (grade 2)
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pericardial Effusion Grade 1
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Neuropahty: sensory
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Mood alteration - Depression
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Hemoglobin
    Additional description: Standard Laboratory Assessment
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 19 (31.58%)
    8 / 19 (42.11%)
    7 / 14 (50.00%)
    6 / 13 (46.15%)
    5 / 12 (41.67%)
         occurrences all number
    6
    8
    7
    6
    5
    Leucocytes
    Additional description: Standard Laboratory Assessment
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 19 (36.84%)
    6 / 19 (31.58%)
    3 / 14 (21.43%)
    2 / 13 (15.38%)
    3 / 12 (25.00%)
         occurrences all number
    7
    6
    3
    2
    3
    Neutrophils
    Additional description: Standard Laboratory Assessment
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 19 (21.05%)
    5 / 19 (26.32%)
    4 / 14 (28.57%)
    4 / 13 (30.77%)
    4 / 12 (33.33%)
         occurrences all number
    4
    5
    4
    4
    4
    Platelets
    Additional description: Standard Laboratory Assessment
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 19 (52.63%)
    10 / 19 (52.63%)
    7 / 14 (50.00%)
    5 / 13 (38.46%)
    6 / 12 (50.00%)
         occurrences all number
    10
    10
    7
    5
    6
    Eye disorders
    Eylid dysfunction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 19 (15.79%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 19 (15.79%)
    2 / 14 (14.29%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    2
    0
    0
    Mucositis/Stomatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    4 / 13 (30.77%)
    5 / 12 (41.67%)
         occurrences all number
    0
    0
    0
    4
    5
    Diarrhea
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    0
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolic/Laboratory - GGT
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 19 (15.79%)
    3 / 14 (21.43%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    3
    3
    1
    1
    Skin and subcutaneous tissue disorders
    Rash Dermatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Renal and urinary disorders
    Renal failure
    Additional description: Only cases without SAE-report summarized
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    1
    Infections and infestations
    Febrile neutropenia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    infection with grade 3-4 ANC
    Additional description: (middle ear)
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infection with unknown ANC
    Additional description: cases of infections without SAE cirteria
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    2 / 14 (14.29%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    2
    1
    1
    Metabolism and nutrition disorders
    Metabolic/Laboratory - ALT
    Additional description: Standard Laboratory Assessment, only cases without SAE-report summarized
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    0
    0
    1
    Metabolic/Laboratory - AST
    Additional description: Standard Laboratory Assessment, only cases without SAE-report summarized
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolic/Laboratory - Bilirubin
    Additional description: Standard Laboratory Assessment, only cases without SAE-report summarized
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 19 (15.79%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    Metabolic/Lab - Other (FSP D-Dimer)
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Apr 2013
    30.04.2013 - Temporary halt of the study. Due to interim safety results, recruitment put on hold until planned protocol amendment 30.9.2015 - “Study End” (i.e. final decision not to reopen/restart the trial with amended chemotherapy backbone and study-protocol)
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None, due to interim results recruitment was prematurely stoped
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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